Trial Outcomes & Findings for Acalabrutinib, Umbralisib, and Ublituximab for the Treatment of Previously Untreated Mantle Cell Lymphoma (NCT NCT04783415)

Last Updated: 2024-12-02

Results Overview

Defined as the proportion of response-evaluable participants that achieve a CR at the end of the induction therapy. CR rate after the induction therapy was estimated by the proportion of response-evaluable patients achieving CR after the induction therapy, along with the 95% exact binomial confidence interval.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

12 participants

Primary outcome timeframe

Participants were assessed at the end of the induction therapy (24 weeks post-baseline). The induction therapy included six 28-day cycles of the study treatment.

Results posted on

2024-12-02

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment (Ublituximab, Acalabrutinib, Umbralisib) Patients receive ublituximab IV over 90 minutes-4 hours on days 1, 8, and 15 of cycle 1 and days 1 of cycles 2-6. Patients also receive acalabrutinib PO BID and umbralisib PO QD on days 1-28. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Patients receive ublituximab IV on day 1 on cycles 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30. Patients also receive acalabrutinib Po BID and umbralisib PO QD on day 1-28. Treatment repeats every 28 days for 24 cycles in the absence of disease progression of unacceptable toxicity. Acalabrutinib: Given PO Ublituximab: Given IV Umbralisib: Given PO
Overall Study STARTED	12
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Acalabrutinib, Umbralisib, and Ublituximab for the Treatment of Previously Untreated Mantle Cell Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Ublituximab, Acalabrutinib, Umbralisib) n=12 Participants Patients receive ublituximab IV over 90 minutes-4 hours on days 1, 8, and 15 of cycle 1 and days 1 of cycles 2-6. Patients also receive acalabrutinib PO BID and umbralisib PO QD on days 1-28. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Patients receive ublituximab IV on day 1 on cycles 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30. Patients also receive acalabrutinib Po BID and umbralisib PO QD on day 1-28. Treatment repeats every 28 days for 24 cycles in the absence of disease progression of unacceptable toxicity. Acalabrutinib: Given PO Ublituximab: Given IV Umbralisib: Given PO
Age, Continuous	70 years n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	12 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants

PRIMARY outcome

Timeframe: Participants were assessed at the end of the induction therapy (24 weeks post-baseline). The induction therapy included six 28-day cycles of the study treatment.

Outcome measures

Outcome measures
Measure	Treatment (Ublituximab, Acalabrutinib, Umbralisib) n=12 Participants Patients receive ublituximab IV over 90 minutes-4 hours on days 1, 8, and 15 of cycle 1 and days 1 of cycles 2-6. Patients also receive acalabrutinib PO BID and umbralisib PO QD on days 1-28. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Patients receive ublituximab IV on day 1 on cycles 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30. Patients also receive acalabrutinib Po BID and umbralisib PO QD on day 1-28. Treatment repeats every 28 days for 24 cycles in the absence of disease progression of unacceptable toxicity. Acalabrutinib: Given PO Ublituximab: Given IV Umbralisib: Given PO
Complete Response (CR) Rate After Induction (Six Cycles)	100 percentage of participants

SECONDARY outcome

Timeframe: Participants were followed up to 24 months after the end of protocol therapy.

Defined as the proportion of response-evaluable participants that achieve a best response of either CR or partial response (PR) during protocol therapy. ORR rate after induction therapy was estimated by the proportion of response-evaluable patients achieving ORR after induction therapy, along with the 95% exact binomial confidence interval.

Outcome measures

Outcome data not reported

Adverse Events

Treatment (Ublituximab, Acalabrutinib, Umbralisib)

Serious events: 4 serious events

Other events: 12 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Ublituximab, Acalabrutinib, Umbralisib) n=12 participants at risk Patients receive ublituximab IV over 90 minutes-4 hours on days 1, 8, and 15 of cycle 1 and days 1 of cycles 2-6. Patients also receive acalabrutinib PO BID and umbralisib PO QD on days 1-28. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Patients receive ublituximab IV on day 1 on cycles 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30. Patients also receive acalabrutinib Po BID and umbralisib PO QD on day 1-28. Treatment repeats every 28 days for 24 cycles in the absence of disease progression of unacceptable toxicity. Acalabrutinib: Given PO Ublituximab: Given IV Umbralisib: Given PO
Cardiac disorders Supraventricular tachycardia	8.3% 1/12 • Number of events 1 • Adverse Events were monitored/assessed at each 28-day cycle treatment and up to 30 days at the end of the protocol therapy. Currently, patients received the study treatment up to 12 cycles. All-Cause Mortality was monitored/assessed up to 30 months from the start time of the initial treatment.
Infections and infestations Covid-19	8.3% 1/12 • Number of events 1 • Adverse Events were monitored/assessed at each 28-day cycle treatment and up to 30 days at the end of the protocol therapy. Currently, patients received the study treatment up to 12 cycles. All-Cause Mortality was monitored/assessed up to 30 months from the start time of the initial treatment.
Infections and infestations Meningitis	8.3% 1/12 • Number of events 1 • Adverse Events were monitored/assessed at each 28-day cycle treatment and up to 30 days at the end of the protocol therapy. Currently, patients received the study treatment up to 12 cycles. All-Cause Mortality was monitored/assessed up to 30 months from the start time of the initial treatment.
Injury, poisoning and procedural complications Infusion related reaction	8.3% 1/12 • Number of events 1 • Adverse Events were monitored/assessed at each 28-day cycle treatment and up to 30 days at the end of the protocol therapy. Currently, patients received the study treatment up to 12 cycles. All-Cause Mortality was monitored/assessed up to 30 months from the start time of the initial treatment.
Investigations Alanine aminotransferase increased	8.3% 1/12 • Number of events 1 • Adverse Events were monitored/assessed at each 28-day cycle treatment and up to 30 days at the end of the protocol therapy. Currently, patients received the study treatment up to 12 cycles. All-Cause Mortality was monitored/assessed up to 30 months from the start time of the initial treatment.
Investigations Aspartate aminotransferase increased	8.3% 1/12 • Number of events 1 • Adverse Events were monitored/assessed at each 28-day cycle treatment and up to 30 days at the end of the protocol therapy. Currently, patients received the study treatment up to 12 cycles. All-Cause Mortality was monitored/assessed up to 30 months from the start time of the initial treatment.

Other adverse events

Other adverse events
Measure	Treatment (Ublituximab, Acalabrutinib, Umbralisib) n=12 participants at risk Patients receive ublituximab IV over 90 minutes-4 hours on days 1, 8, and 15 of cycle 1 and days 1 of cycles 2-6. Patients also receive acalabrutinib PO BID and umbralisib PO QD on days 1-28. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Patients receive ublituximab IV on day 1 on cycles 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30. Patients also receive acalabrutinib Po BID and umbralisib PO QD on day 1-28. Treatment repeats every 28 days for 24 cycles in the absence of disease progression of unacceptable toxicity. Acalabrutinib: Given PO Ublituximab: Given IV Umbralisib: Given PO
Blood and lymphatic system disorders Anemia	66.7% 8/12 • Number of events 13 • Adverse Events were monitored/assessed at each 28-day cycle treatment and up to 30 days at the end of the protocol therapy. Currently, patients received the study treatment up to 12 cycles. All-Cause Mortality was monitored/assessed up to 30 months from the start time of the initial treatment.
Cardiac disorders Palpitations	8.3% 1/12 • Number of events 1 • Adverse Events were monitored/assessed at each 28-day cycle treatment and up to 30 days at the end of the protocol therapy. Currently, patients received the study treatment up to 12 cycles. All-Cause Mortality was monitored/assessed up to 30 months from the start time of the initial treatment.
Cardiac disorders Sinus tachycardia	41.7% 5/12 • Number of events 5 • Adverse Events were monitored/assessed at each 28-day cycle treatment and up to 30 days at the end of the protocol therapy. Currently, patients received the study treatment up to 12 cycles. All-Cause Mortality was monitored/assessed up to 30 months from the start time of the initial treatment.
Gastrointestinal disorders Abdominal distension	8.3% 1/12 • Number of events 1 • Adverse Events were monitored/assessed at each 28-day cycle treatment and up to 30 days at the end of the protocol therapy. Currently, patients received the study treatment up to 12 cycles. All-Cause Mortality was monitored/assessed up to 30 months from the start time of the initial treatment.
Gastrointestinal disorders Abdominal pain	41.7% 5/12 • Number of events 7 • Adverse Events were monitored/assessed at each 28-day cycle treatment and up to 30 days at the end of the protocol therapy. Currently, patients received the study treatment up to 12 cycles. All-Cause Mortality was monitored/assessed up to 30 months from the start time of the initial treatment.
Gastrointestinal disorders BELCHING	8.3% 1/12 • Number of events 1 • Adverse Events were monitored/assessed at each 28-day cycle treatment and up to 30 days at the end of the protocol therapy. Currently, patients received the study treatment up to 12 cycles. All-Cause Mortality was monitored/assessed up to 30 months from the start time of the initial treatment.
Gastrointestinal disorders Constipation	25.0% 3/12 • Number of events 3 • Adverse Events were monitored/assessed at each 28-day cycle treatment and up to 30 days at the end of the protocol therapy. Currently, patients received the study treatment up to 12 cycles. All-Cause Mortality was monitored/assessed up to 30 months from the start time of the initial treatment.
Gastrointestinal disorders Diarrhea	91.7% 11/12 • Number of events 30 • Adverse Events were monitored/assessed at each 28-day cycle treatment and up to 30 days at the end of the protocol therapy. Currently, patients received the study treatment up to 12 cycles. All-Cause Mortality was monitored/assessed up to 30 months from the start time of the initial treatment.
Gastrointestinal disorders Dry mouth	8.3% 1/12 • Number of events 1 • Adverse Events were monitored/assessed at each 28-day cycle treatment and up to 30 days at the end of the protocol therapy. Currently, patients received the study treatment up to 12 cycles. All-Cause Mortality was monitored/assessed up to 30 months from the start time of the initial treatment.
Gastrointestinal disorders Dyspepsia	16.7% 2/12 • Number of events 2 • Adverse Events were monitored/assessed at each 28-day cycle treatment and up to 30 days at the end of the protocol therapy. Currently, patients received the study treatment up to 12 cycles. All-Cause Mortality was monitored/assessed up to 30 months from the start time of the initial treatment.
Gastrointestinal disorders Flatulence	8.3% 1/12 • Number of events 1 • Adverse Events were monitored/assessed at each 28-day cycle treatment and up to 30 days at the end of the protocol therapy. Currently, patients received the study treatment up to 12 cycles. All-Cause Mortality was monitored/assessed up to 30 months from the start time of the initial treatment.
Gastrointestinal disorders Gastroesophageal reflux disease	8.3% 1/12 • Number of events 2 • Adverse Events were monitored/assessed at each 28-day cycle treatment and up to 30 days at the end of the protocol therapy. Currently, patients received the study treatment up to 12 cycles. All-Cause Mortality was monitored/assessed up to 30 months from the start time of the initial treatment.
Gastrointestinal disorders HEARTBURN	8.3% 1/12 • Number of events 1 • Adverse Events were monitored/assessed at each 28-day cycle treatment and up to 30 days at the end of the protocol therapy. Currently, patients received the study treatment up to 12 cycles. All-Cause Mortality was monitored/assessed up to 30 months from the start time of the initial treatment.
Gastrointestinal disorders Hemorrhoids	8.3% 1/12 • Number of events 1 • Adverse Events were monitored/assessed at each 28-day cycle treatment and up to 30 days at the end of the protocol therapy. Currently, patients received the study treatment up to 12 cycles. All-Cause Mortality was monitored/assessed up to 30 months from the start time of the initial treatment.
Gastrointestinal disorders MILD CHEST DISCOMFORT	8.3% 1/12 • Number of events 1 • Adverse Events were monitored/assessed at each 28-day cycle treatment and up to 30 days at the end of the protocol therapy. Currently, patients received the study treatment up to 12 cycles. All-Cause Mortality was monitored/assessed up to 30 months from the start time of the initial treatment.
Gastrointestinal disorders Mucositis oral	8.3% 1/12 • Number of events 1 • Adverse Events were monitored/assessed at each 28-day cycle treatment and up to 30 days at the end of the protocol therapy. Currently, patients received the study treatment up to 12 cycles. All-Cause Mortality was monitored/assessed up to 30 months from the start time of the initial treatment.
Gastrointestinal disorders Nausea	58.3% 7/12 • Number of events 12 • Adverse Events were monitored/assessed at each 28-day cycle treatment and up to 30 days at the end of the protocol therapy. Currently, patients received the study treatment up to 12 cycles. All-Cause Mortality was monitored/assessed up to 30 months from the start time of the initial treatment.
Gastrointestinal disorders Oral pain	8.3% 1/12 • Number of events 1 • Adverse Events were monitored/assessed at each 28-day cycle treatment and up to 30 days at the end of the protocol therapy. Currently, patients received the study treatment up to 12 cycles. All-Cause Mortality was monitored/assessed up to 30 months from the start time of the initial treatment.
Gastrointestinal disorders Vomiting	50.0% 6/12 • Number of events 13 • Adverse Events were monitored/assessed at each 28-day cycle treatment and up to 30 days at the end of the protocol therapy. Currently, patients received the study treatment up to 12 cycles. All-Cause Mortality was monitored/assessed up to 30 months from the start time of the initial treatment.
General disorders Chills	16.7% 2/12 • Number of events 2 • Adverse Events were monitored/assessed at each 28-day cycle treatment and up to 30 days at the end of the protocol therapy. Currently, patients received the study treatment up to 12 cycles. All-Cause Mortality was monitored/assessed up to 30 months from the start time of the initial treatment.
General disorders Edema limbs	25.0% 3/12 • Number of events 5 • Adverse Events were monitored/assessed at each 28-day cycle treatment and up to 30 days at the end of the protocol therapy. Currently, patients received the study treatment up to 12 cycles. All-Cause Mortality was monitored/assessed up to 30 months from the start time of the initial treatment.
General disorders Facial pain	8.3% 1/12 • Number of events 2 • Adverse Events were monitored/assessed at each 28-day cycle treatment and up to 30 days at the end of the protocol therapy. Currently, patients received the study treatment up to 12 cycles. All-Cause Mortality was monitored/assessed up to 30 months from the start time of the initial treatment.
General disorders Fatigue	41.7% 5/12 • Number of events 6 • Adverse Events were monitored/assessed at each 28-day cycle treatment and up to 30 days at the end of the protocol therapy. Currently, patients received the study treatment up to 12 cycles. All-Cause Mortality was monitored/assessed up to 30 months from the start time of the initial treatment.
General disorders Fever	16.7% 2/12 • Number of events 3 • Adverse Events were monitored/assessed at each 28-day cycle treatment and up to 30 days at the end of the protocol therapy. Currently, patients received the study treatment up to 12 cycles. All-Cause Mortality was monitored/assessed up to 30 months from the start time of the initial treatment.
General disorders Flu like symptoms	16.7% 2/12 • Number of events 2 • Adverse Events were monitored/assessed at each 28-day cycle treatment and up to 30 days at the end of the protocol therapy. Currently, patients received the study treatment up to 12 cycles. All-Cause Mortality was monitored/assessed up to 30 months from the start time of the initial treatment.
General disorders Malaise	16.7% 2/12 • Number of events 2 • Adverse Events were monitored/assessed at each 28-day cycle treatment and up to 30 days at the end of the protocol therapy. Currently, patients received the study treatment up to 12 cycles. All-Cause Mortality was monitored/assessed up to 30 months from the start time of the initial treatment.
General disorders Non-cardiac chest pain	16.7% 2/12 • Number of events 2 • Adverse Events were monitored/assessed at each 28-day cycle treatment and up to 30 days at the end of the protocol therapy. Currently, patients received the study treatment up to 12 cycles. All-Cause Mortality was monitored/assessed up to 30 months from the start time of the initial treatment.
General disorders Pain	8.3% 1/12 • Number of events 1 • Adverse Events were monitored/assessed at each 28-day cycle treatment and up to 30 days at the end of the protocol therapy. Currently, patients received the study treatment up to 12 cycles. All-Cause Mortality was monitored/assessed up to 30 months from the start time of the initial treatment.
Infections and infestations COVID-19	16.7% 2/12 • Number of events 2 • Adverse Events were monitored/assessed at each 28-day cycle treatment and up to 30 days at the end of the protocol therapy. Currently, patients received the study treatment up to 12 cycles. All-Cause Mortality was monitored/assessed up to 30 months from the start time of the initial treatment.
Infections and infestations Allergic Conjunctivities	8.3% 1/12 • Number of events 1 • Adverse Events were monitored/assessed at each 28-day cycle treatment and up to 30 days at the end of the protocol therapy. Currently, patients received the study treatment up to 12 cycles. All-Cause Mortality was monitored/assessed up to 30 months from the start time of the initial treatment.
Infections and infestations Eye infection	8.3% 1/12 • Number of events 1 • Adverse Events were monitored/assessed at each 28-day cycle treatment and up to 30 days at the end of the protocol therapy. Currently, patients received the study treatment up to 12 cycles. All-Cause Mortality was monitored/assessed up to 30 months from the start time of the initial treatment.
Infections and infestations Lung infection	8.3% 1/12 • Number of events 1 • Adverse Events were monitored/assessed at each 28-day cycle treatment and up to 30 days at the end of the protocol therapy. Currently, patients received the study treatment up to 12 cycles. All-Cause Mortality was monitored/assessed up to 30 months from the start time of the initial treatment.
Infections and infestations Skin infection	8.3% 1/12 • Number of events 1 • Adverse Events were monitored/assessed at each 28-day cycle treatment and up to 30 days at the end of the protocol therapy. Currently, patients received the study treatment up to 12 cycles. All-Cause Mortality was monitored/assessed up to 30 months from the start time of the initial treatment.
Infections and infestations Thrush	8.3% 1/12 • Number of events 1 • Adverse Events were monitored/assessed at each 28-day cycle treatment and up to 30 days at the end of the protocol therapy. Currently, patients received the study treatment up to 12 cycles. All-Cause Mortality was monitored/assessed up to 30 months from the start time of the initial treatment.
Infections and infestations Upper respiratory infection	16.7% 2/12 • Number of events 2 • Adverse Events were monitored/assessed at each 28-day cycle treatment and up to 30 days at the end of the protocol therapy. Currently, patients received the study treatment up to 12 cycles. All-Cause Mortality was monitored/assessed up to 30 months from the start time of the initial treatment.
Injury, poisoning and procedural complications Bruising	33.3% 4/12 • Number of events 5 • Adverse Events were monitored/assessed at each 28-day cycle treatment and up to 30 days at the end of the protocol therapy. Currently, patients received the study treatment up to 12 cycles. All-Cause Mortality was monitored/assessed up to 30 months from the start time of the initial treatment.
Injury, poisoning and procedural complications Infusion related reaction	75.0% 9/12 • Number of events 12 • Adverse Events were monitored/assessed at each 28-day cycle treatment and up to 30 days at the end of the protocol therapy. Currently, patients received the study treatment up to 12 cycles. All-Cause Mortality was monitored/assessed up to 30 months from the start time of the initial treatment.
Investigations Alanine aminotransferase increased	33.3% 4/12 • Number of events 11 • Adverse Events were monitored/assessed at each 28-day cycle treatment and up to 30 days at the end of the protocol therapy. Currently, patients received the study treatment up to 12 cycles. All-Cause Mortality was monitored/assessed up to 30 months from the start time of the initial treatment.
Investigations Alkaline phosphatase increased	25.0% 3/12 • Number of events 6 • Adverse Events were monitored/assessed at each 28-day cycle treatment and up to 30 days at the end of the protocol therapy. Currently, patients received the study treatment up to 12 cycles. All-Cause Mortality was monitored/assessed up to 30 months from the start time of the initial treatment.
Investigations Aspartate aminotransferase increased	66.7% 8/12 • Number of events 16 • Adverse Events were monitored/assessed at each 28-day cycle treatment and up to 30 days at the end of the protocol therapy. Currently, patients received the study treatment up to 12 cycles. All-Cause Mortality was monitored/assessed up to 30 months from the start time of the initial treatment.
Investigations Blood bilirubin increased	8.3% 1/12 • Number of events 4 • Adverse Events were monitored/assessed at each 28-day cycle treatment and up to 30 days at the end of the protocol therapy. Currently, patients received the study treatment up to 12 cycles. All-Cause Mortality was monitored/assessed up to 30 months from the start time of the initial treatment.
Investigations Blood lactate dehydrogenase increased	66.7% 8/12 • Number of events 10 • Adverse Events were monitored/assessed at each 28-day cycle treatment and up to 30 days at the end of the protocol therapy. Currently, patients received the study treatment up to 12 cycles. All-Cause Mortality was monitored/assessed up to 30 months from the start time of the initial treatment.
Investigations Creatinine increased	33.3% 4/12 • Number of events 5 • Adverse Events were monitored/assessed at each 28-day cycle treatment and up to 30 days at the end of the protocol therapy. Currently, patients received the study treatment up to 12 cycles. All-Cause Mortality was monitored/assessed up to 30 months from the start time of the initial treatment.
Investigations Lymphocyte count decreased	33.3% 4/12 • Number of events 7 • Adverse Events were monitored/assessed at each 28-day cycle treatment and up to 30 days at the end of the protocol therapy. Currently, patients received the study treatment up to 12 cycles. All-Cause Mortality was monitored/assessed up to 30 months from the start time of the initial treatment.
Investigations Lymphocyte count increased	8.3% 1/12 • Number of events 1 • Adverse Events were monitored/assessed at each 28-day cycle treatment and up to 30 days at the end of the protocol therapy. Currently, patients received the study treatment up to 12 cycles. All-Cause Mortality was monitored/assessed up to 30 months from the start time of the initial treatment.
Investigations Neutrophil count decreased	33.3% 4/12 • Number of events 9 • Adverse Events were monitored/assessed at each 28-day cycle treatment and up to 30 days at the end of the protocol therapy. Currently, patients received the study treatment up to 12 cycles. All-Cause Mortality was monitored/assessed up to 30 months from the start time of the initial treatment.
Investigations Platelet count decreased	58.3% 7/12 • Number of events 11 • Adverse Events were monitored/assessed at each 28-day cycle treatment and up to 30 days at the end of the protocol therapy. Currently, patients received the study treatment up to 12 cycles. All-Cause Mortality was monitored/assessed up to 30 months from the start time of the initial treatment.
Investigations Weight gain	41.7% 5/12 • Number of events 5 • Adverse Events were monitored/assessed at each 28-day cycle treatment and up to 30 days at the end of the protocol therapy. Currently, patients received the study treatment up to 12 cycles. All-Cause Mortality was monitored/assessed up to 30 months from the start time of the initial treatment.
Investigations Weight loss	41.7% 5/12 • Number of events 7 • Adverse Events were monitored/assessed at each 28-day cycle treatment and up to 30 days at the end of the protocol therapy. Currently, patients received the study treatment up to 12 cycles. All-Cause Mortality was monitored/assessed up to 30 months from the start time of the initial treatment.
Investigations White blood cell decreased	41.7% 5/12 • Number of events 9 • Adverse Events were monitored/assessed at each 28-day cycle treatment and up to 30 days at the end of the protocol therapy. Currently, patients received the study treatment up to 12 cycles. All-Cause Mortality was monitored/assessed up to 30 months from the start time of the initial treatment.
Metabolism and nutrition disorders Anorexia	8.3% 1/12 • Number of events 1 • Adverse Events were monitored/assessed at each 28-day cycle treatment and up to 30 days at the end of the protocol therapy. Currently, patients received the study treatment up to 12 cycles. All-Cause Mortality was monitored/assessed up to 30 months from the start time of the initial treatment.
Metabolism and nutrition disorders Dehydration	8.3% 1/12 • Number of events 1 • Adverse Events were monitored/assessed at each 28-day cycle treatment and up to 30 days at the end of the protocol therapy. Currently, patients received the study treatment up to 12 cycles. All-Cause Mortality was monitored/assessed up to 30 months from the start time of the initial treatment.
Metabolism and nutrition disorders Hyperglycemia	66.7% 8/12 • Number of events 13 • Adverse Events were monitored/assessed at each 28-day cycle treatment and up to 30 days at the end of the protocol therapy. Currently, patients received the study treatment up to 12 cycles. All-Cause Mortality was monitored/assessed up to 30 months from the start time of the initial treatment.
Metabolism and nutrition disorders Hyperkalemia	16.7% 2/12 • Number of events 2 • Adverse Events were monitored/assessed at each 28-day cycle treatment and up to 30 days at the end of the protocol therapy. Currently, patients received the study treatment up to 12 cycles. All-Cause Mortality was monitored/assessed up to 30 months from the start time of the initial treatment.
Metabolism and nutrition disorders Hypermagnesemia	41.7% 5/12 • Number of events 5 • Adverse Events were monitored/assessed at each 28-day cycle treatment and up to 30 days at the end of the protocol therapy. Currently, patients received the study treatment up to 12 cycles. All-Cause Mortality was monitored/assessed up to 30 months from the start time of the initial treatment.
Metabolism and nutrition disorders Hypernatremia	8.3% 1/12 • Number of events 1 • Adverse Events were monitored/assessed at each 28-day cycle treatment and up to 30 days at the end of the protocol therapy. Currently, patients received the study treatment up to 12 cycles. All-Cause Mortality was monitored/assessed up to 30 months from the start time of the initial treatment.
Metabolism and nutrition disorders Hyperphosphatemia	41.7% 5/12 • Number of events 6 • Adverse Events were monitored/assessed at each 28-day cycle treatment and up to 30 days at the end of the protocol therapy. Currently, patients received the study treatment up to 12 cycles. All-Cause Mortality was monitored/assessed up to 30 months from the start time of the initial treatment.
Metabolism and nutrition disorders Hyperuricemia	25.0% 3/12 • Number of events 3 • Adverse Events were monitored/assessed at each 28-day cycle treatment and up to 30 days at the end of the protocol therapy. Currently, patients received the study treatment up to 12 cycles. All-Cause Mortality was monitored/assessed up to 30 months from the start time of the initial treatment.
Metabolism and nutrition disorders Hypoalbuminemia	16.7% 2/12 • Number of events 3 • Adverse Events were monitored/assessed at each 28-day cycle treatment and up to 30 days at the end of the protocol therapy. Currently, patients received the study treatment up to 12 cycles. All-Cause Mortality was monitored/assessed up to 30 months from the start time of the initial treatment.
Metabolism and nutrition disorders Hypocalcemia	16.7% 2/12 • Number of events 2 • Adverse Events were monitored/assessed at each 28-day cycle treatment and up to 30 days at the end of the protocol therapy. Currently, patients received the study treatment up to 12 cycles. All-Cause Mortality was monitored/assessed up to 30 months from the start time of the initial treatment.
Metabolism and nutrition disorders Hypoglycemia	75.0% 9/12 • Number of events 14 • Adverse Events were monitored/assessed at each 28-day cycle treatment and up to 30 days at the end of the protocol therapy. Currently, patients received the study treatment up to 12 cycles. All-Cause Mortality was monitored/assessed up to 30 months from the start time of the initial treatment.
Metabolism and nutrition disorders Hypokalemia	8.3% 1/12 • Number of events 1 • Adverse Events were monitored/assessed at each 28-day cycle treatment and up to 30 days at the end of the protocol therapy. Currently, patients received the study treatment up to 12 cycles. All-Cause Mortality was monitored/assessed up to 30 months from the start time of the initial treatment.
Metabolism and nutrition disorders Hyponatremia	58.3% 7/12 • Number of events 13 • Adverse Events were monitored/assessed at each 28-day cycle treatment and up to 30 days at the end of the protocol therapy. Currently, patients received the study treatment up to 12 cycles. All-Cause Mortality was monitored/assessed up to 30 months from the start time of the initial treatment.
Metabolism and nutrition disorders Hypophosphatemia	25.0% 3/12 • Number of events 3 • Adverse Events were monitored/assessed at each 28-day cycle treatment and up to 30 days at the end of the protocol therapy. Currently, patients received the study treatment up to 12 cycles. All-Cause Mortality was monitored/assessed up to 30 months from the start time of the initial treatment.
Metabolism and nutrition disorders Tumor lysis syndrome	8.3% 1/12 • Number of events 1 • Adverse Events were monitored/assessed at each 28-day cycle treatment and up to 30 days at the end of the protocol therapy. Currently, patients received the study treatment up to 12 cycles. All-Cause Mortality was monitored/assessed up to 30 months from the start time of the initial treatment.
Musculoskeletal and connective tissue disorders Arthralgia	8.3% 1/12 • Number of events 1 • Adverse Events were monitored/assessed at each 28-day cycle treatment and up to 30 days at the end of the protocol therapy. Currently, patients received the study treatment up to 12 cycles. All-Cause Mortality was monitored/assessed up to 30 months from the start time of the initial treatment.
Musculoskeletal and connective tissue disorders Back pain	25.0% 3/12 • Number of events 3 • Adverse Events were monitored/assessed at each 28-day cycle treatment and up to 30 days at the end of the protocol therapy. Currently, patients received the study treatment up to 12 cycles. All-Cause Mortality was monitored/assessed up to 30 months from the start time of the initial treatment.
Musculoskeletal and connective tissue disorders Bone pain	16.7% 2/12 • Number of events 2 • Adverse Events were monitored/assessed at each 28-day cycle treatment and up to 30 days at the end of the protocol therapy. Currently, patients received the study treatment up to 12 cycles. All-Cause Mortality was monitored/assessed up to 30 months from the start time of the initial treatment.
Musculoskeletal and connective tissue disorders Flank pain	8.3% 1/12 • Number of events 1 • Adverse Events were monitored/assessed at each 28-day cycle treatment and up to 30 days at the end of the protocol therapy. Currently, patients received the study treatment up to 12 cycles. All-Cause Mortality was monitored/assessed up to 30 months from the start time of the initial treatment.
Musculoskeletal and connective tissue disorders Muscle cramp	8.3% 1/12 • Number of events 1 • Adverse Events were monitored/assessed at each 28-day cycle treatment and up to 30 days at the end of the protocol therapy. Currently, patients received the study treatment up to 12 cycles. All-Cause Mortality was monitored/assessed up to 30 months from the start time of the initial treatment.
Musculoskeletal and connective tissue disorders Myalgia	16.7% 2/12 • Number of events 2 • Adverse Events were monitored/assessed at each 28-day cycle treatment and up to 30 days at the end of the protocol therapy. Currently, patients received the study treatment up to 12 cycles. All-Cause Mortality was monitored/assessed up to 30 months from the start time of the initial treatment.
Musculoskeletal and connective tissue disorders Neck pain	8.3% 1/12 • Number of events 1 • Adverse Events were monitored/assessed at each 28-day cycle treatment and up to 30 days at the end of the protocol therapy. Currently, patients received the study treatment up to 12 cycles. All-Cause Mortality was monitored/assessed up to 30 months from the start time of the initial treatment.
Musculoskeletal and connective tissue disorders Pain in extremity	16.7% 2/12 • Number of events 2 • Adverse Events were monitored/assessed at each 28-day cycle treatment and up to 30 days at the end of the protocol therapy. Currently, patients received the study treatment up to 12 cycles. All-Cause Mortality was monitored/assessed up to 30 months from the start time of the initial treatment.
Nervous system disorders Dizziness	33.3% 4/12 • Number of events 5 • Adverse Events were monitored/assessed at each 28-day cycle treatment and up to 30 days at the end of the protocol therapy. Currently, patients received the study treatment up to 12 cycles. All-Cause Mortality was monitored/assessed up to 30 months from the start time of the initial treatment.
Nervous system disorders Dysgeusia	16.7% 2/12 • Number of events 2 • Adverse Events were monitored/assessed at each 28-day cycle treatment and up to 30 days at the end of the protocol therapy. Currently, patients received the study treatment up to 12 cycles. All-Cause Mortality was monitored/assessed up to 30 months from the start time of the initial treatment.
Nervous system disorders Headache	58.3% 7/12 • Number of events 9 • Adverse Events were monitored/assessed at each 28-day cycle treatment and up to 30 days at the end of the protocol therapy. Currently, patients received the study treatment up to 12 cycles. All-Cause Mortality was monitored/assessed up to 30 months from the start time of the initial treatment.
Nervous system disorders Paresthesia	16.7% 2/12 • Number of events 2 • Adverse Events were monitored/assessed at each 28-day cycle treatment and up to 30 days at the end of the protocol therapy. Currently, patients received the study treatment up to 12 cycles. All-Cause Mortality was monitored/assessed up to 30 months from the start time of the initial treatment.
Nervous system disorders Peripheral sensory neuropathy	8.3% 1/12 • Number of events 1 • Adverse Events were monitored/assessed at each 28-day cycle treatment and up to 30 days at the end of the protocol therapy. Currently, patients received the study treatment up to 12 cycles. All-Cause Mortality was monitored/assessed up to 30 months from the start time of the initial treatment.
Psychiatric disorders Anxiety	8.3% 1/12 • Number of events 1 • Adverse Events were monitored/assessed at each 28-day cycle treatment and up to 30 days at the end of the protocol therapy. Currently, patients received the study treatment up to 12 cycles. All-Cause Mortality was monitored/assessed up to 30 months from the start time of the initial treatment.
Psychiatric disorders Insomnia	16.7% 2/12 • Number of events 2 • Adverse Events were monitored/assessed at each 28-day cycle treatment and up to 30 days at the end of the protocol therapy. Currently, patients received the study treatment up to 12 cycles. All-Cause Mortality was monitored/assessed up to 30 months from the start time of the initial treatment.
Psychiatric disorders Mania	8.3% 1/12 • Number of events 1 • Adverse Events were monitored/assessed at each 28-day cycle treatment and up to 30 days at the end of the protocol therapy. Currently, patients received the study treatment up to 12 cycles. All-Cause Mortality was monitored/assessed up to 30 months from the start time of the initial treatment.
Psychiatric disorders Psychosis	8.3% 1/12 • Number of events 1 • Adverse Events were monitored/assessed at each 28-day cycle treatment and up to 30 days at the end of the protocol therapy. Currently, patients received the study treatment up to 12 cycles. All-Cause Mortality was monitored/assessed up to 30 months from the start time of the initial treatment.
Psychiatric disorders Restlessness	8.3% 1/12 • Number of events 1 • Adverse Events were monitored/assessed at each 28-day cycle treatment and up to 30 days at the end of the protocol therapy. Currently, patients received the study treatment up to 12 cycles. All-Cause Mortality was monitored/assessed up to 30 months from the start time of the initial treatment.
Renal and urinary disorders Dysuria	8.3% 1/12 • Number of events 1 • Adverse Events were monitored/assessed at each 28-day cycle treatment and up to 30 days at the end of the protocol therapy. Currently, patients received the study treatment up to 12 cycles. All-Cause Mortality was monitored/assessed up to 30 months from the start time of the initial treatment.
Renal and urinary disorders Glucosuria	8.3% 1/12 • Number of events 1 • Adverse Events were monitored/assessed at each 28-day cycle treatment and up to 30 days at the end of the protocol therapy. Currently, patients received the study treatment up to 12 cycles. All-Cause Mortality was monitored/assessed up to 30 months from the start time of the initial treatment.
Renal and urinary disorders Proteinuria	8.3% 1/12 • Number of events 1 • Adverse Events were monitored/assessed at each 28-day cycle treatment and up to 30 days at the end of the protocol therapy. Currently, patients received the study treatment up to 12 cycles. All-Cause Mortality was monitored/assessed up to 30 months from the start time of the initial treatment.
Renal and urinary disorders Urinary frequency	8.3% 1/12 • Number of events 1 • Adverse Events were monitored/assessed at each 28-day cycle treatment and up to 30 days at the end of the protocol therapy. Currently, patients received the study treatment up to 12 cycles. All-Cause Mortality was monitored/assessed up to 30 months from the start time of the initial treatment.
Reproductive system and breast disorders Vaginal dryness	8.3% 1/12 • Number of events 1 • Adverse Events were monitored/assessed at each 28-day cycle treatment and up to 30 days at the end of the protocol therapy. Currently, patients received the study treatment up to 12 cycles. All-Cause Mortality was monitored/assessed up to 30 months from the start time of the initial treatment.
Respiratory, thoracic and mediastinal disorders Bronchitis	8.3% 1/12 • Number of events 1 • Adverse Events were monitored/assessed at each 28-day cycle treatment and up to 30 days at the end of the protocol therapy. Currently, patients received the study treatment up to 12 cycles. All-Cause Mortality was monitored/assessed up to 30 months from the start time of the initial treatment.
Respiratory, thoracic and mediastinal disorders Cough	25.0% 3/12 • Number of events 4 • Adverse Events were monitored/assessed at each 28-day cycle treatment and up to 30 days at the end of the protocol therapy. Currently, patients received the study treatment up to 12 cycles. All-Cause Mortality was monitored/assessed up to 30 months from the start time of the initial treatment.
Respiratory, thoracic and mediastinal disorders Dyspnea	8.3% 1/12 • Number of events 1 • Adverse Events were monitored/assessed at each 28-day cycle treatment and up to 30 days at the end of the protocol therapy. Currently, patients received the study treatment up to 12 cycles. All-Cause Mortality was monitored/assessed up to 30 months from the start time of the initial treatment.
Respiratory, thoracic and mediastinal disorders Epistaxis	8.3% 1/12 • Number of events 1 • Adverse Events were monitored/assessed at each 28-day cycle treatment and up to 30 days at the end of the protocol therapy. Currently, patients received the study treatment up to 12 cycles. All-Cause Mortality was monitored/assessed up to 30 months from the start time of the initial treatment.
Respiratory, thoracic and mediastinal disorders Hiccups	8.3% 1/12 • Number of events 1 • Adverse Events were monitored/assessed at each 28-day cycle treatment and up to 30 days at the end of the protocol therapy. Currently, patients received the study treatment up to 12 cycles. All-Cause Mortality was monitored/assessed up to 30 months from the start time of the initial treatment.
Respiratory, thoracic and mediastinal disorders Productive cough	8.3% 1/12 • Number of events 1 • Adverse Events were monitored/assessed at each 28-day cycle treatment and up to 30 days at the end of the protocol therapy. Currently, patients received the study treatment up to 12 cycles. All-Cause Mortality was monitored/assessed up to 30 months from the start time of the initial treatment.
Respiratory, thoracic and mediastinal disorders Sore throat	8.3% 1/12 • Number of events 1 • Adverse Events were monitored/assessed at each 28-day cycle treatment and up to 30 days at the end of the protocol therapy. Currently, patients received the study treatment up to 12 cycles. All-Cause Mortality was monitored/assessed up to 30 months from the start time of the initial treatment.
Skin and subcutaneous tissue disorders Dry skin	8.3% 1/12 • Number of events 1 • Adverse Events were monitored/assessed at each 28-day cycle treatment and up to 30 days at the end of the protocol therapy. Currently, patients received the study treatment up to 12 cycles. All-Cause Mortality was monitored/assessed up to 30 months from the start time of the initial treatment.
Skin and subcutaneous tissue disorders Hyperhidrosis	8.3% 1/12 • Number of events 1 • Adverse Events were monitored/assessed at each 28-day cycle treatment and up to 30 days at the end of the protocol therapy. Currently, patients received the study treatment up to 12 cycles. All-Cause Mortality was monitored/assessed up to 30 months from the start time of the initial treatment.
Skin and subcutaneous tissue disorders Petechiae	8.3% 1/12 • Number of events 1 • Adverse Events were monitored/assessed at each 28-day cycle treatment and up to 30 days at the end of the protocol therapy. Currently, patients received the study treatment up to 12 cycles. All-Cause Mortality was monitored/assessed up to 30 months from the start time of the initial treatment.
Skin and subcutaneous tissue disorders Pruritus	25.0% 3/12 • Number of events 3 • Adverse Events were monitored/assessed at each 28-day cycle treatment and up to 30 days at the end of the protocol therapy. Currently, patients received the study treatment up to 12 cycles. All-Cause Mortality was monitored/assessed up to 30 months from the start time of the initial treatment.
Skin and subcutaneous tissue disorders Rash maculo-papular	50.0% 6/12 • Number of events 8 • Adverse Events were monitored/assessed at each 28-day cycle treatment and up to 30 days at the end of the protocol therapy. Currently, patients received the study treatment up to 12 cycles. All-Cause Mortality was monitored/assessed up to 30 months from the start time of the initial treatment.
Social circumstances dog bite	8.3% 1/12 • Number of events 1 • Adverse Events were monitored/assessed at each 28-day cycle treatment and up to 30 days at the end of the protocol therapy. Currently, patients received the study treatment up to 12 cycles. All-Cause Mortality was monitored/assessed up to 30 months from the start time of the initial treatment.
Vascular disorders Hot flashes	8.3% 1/12 • Number of events 1 • Adverse Events were monitored/assessed at each 28-day cycle treatment and up to 30 days at the end of the protocol therapy. Currently, patients received the study treatment up to 12 cycles. All-Cause Mortality was monitored/assessed up to 30 months from the start time of the initial treatment.
Vascular disorders Hypertension	75.0% 9/12 • Number of events 29 • Adverse Events were monitored/assessed at each 28-day cycle treatment and up to 30 days at the end of the protocol therapy. Currently, patients received the study treatment up to 12 cycles. All-Cause Mortality was monitored/assessed up to 30 months from the start time of the initial treatment.
Vascular disorders Hypotension	16.7% 2/12 • Number of events 2 • Adverse Events were monitored/assessed at each 28-day cycle treatment and up to 30 days at the end of the protocol therapy. Currently, patients received the study treatment up to 12 cycles. All-Cause Mortality was monitored/assessed up to 30 months from the start time of the initial treatment.

Additional Information

Dr. Alexey Danilov

City of Hope Medical Center

Phone: 626-359-8111

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place